STUDY PURPOSE: To examine the effect of a variety of supportive care measures on quality of life (QOL), depression, anxiety, coping skills, and self-efficacy among men with prostate cancer in various states of care. (Note: Many more outcomes were reported among studies, but the four above were the most frequent.)

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 26  
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,740 participants
• SAMPLE RANGE ACROSS STUDIES: Less than 50 to over 200. Seven were pilot studies. 
• KEY SAMPLE CHARACTERISTICS: Twenty studies were based in the USA (most were government-funded or national research groups), two were based in Canada (similar funding as in USA), and others were based in Ireland, Sweden, or Hong Kong. Other funding sources were public, private, or not described. Seven studies were rated at high risk for bias. One study included patients with breast cancer and prostate cancer in the power calculation. Control group designation, services, or support were inconsistently described across trials.

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Most trials reported no effect of supportive care measures on the stated outcome variables. The findings indicated appropriate interventions and outcomes measures, but small samples with insufficient power contributed to lack of evidence for improvements. Recommendations included resources to support the design, conduct of trials, and reporting (CONSORT guidelines) improvements. Also included were recommendations to diversify sampling across sociodemographic profiles to include unpartnered men who may be less likely to have a social support network, address all stages of care, provide clear descriptions of usual care and control group activities, and use reliable and valid outcome measures.

• Mostly low quality/high risk of bias studies
• Minimal confidence can be put in the study findings as a result of the design and analysis limitations.

The value of this systematic review is that supportive care probably works, but the evidence is lacking because of inconsistencies in study design and reporting. Clear, perhaps standardized, descriptions of the broad variety of interventions called \"supportive care\" are needed. Comparative information was not available across more than two to six trials of a particular intervention. The effect of supportive care in patients with prostate cancer can be examined by creating studies that have strong design quality and methodology. The authors’ provide important recommendations for study areas to be addressed so that results are comparable. One finding is seldom sufficient to change or influence practice.

Two studies evaluated patient anxiety using the Spielberger State-Trait Anxiety Inventory. Anxiety declined in both study groups, but the reduction in anxiety was significantly greater in the control group (n = 169, SMD = .4, p = .02). Other results of training explored were sensitivity of communications, display of empathy, patient trust, quality of life, and patient recall of information, distress, and satisfaction. One study showed no impact on patient depression.

Provider communication skill training was not shown to have a positive effect on patients' level of anxiety or depression. Physician training was more likely to result in communications showing empathy.

Type, duration, and timing of training interventions were very diverse, making the synthesis of findings difficult. Similarly, the timing of study follow-up assessments varied. For the individual outcomes examined, the number of available studies was small.

Communication skill training is likely to improve some communication skills of providers, but evidence regarding any impact of this on patient outcomes is lacking, and long-term effects are unknown. The most effective training method also is unclear. Given the current emphasis on shared decision-making and patient-centered care, the importance of provider communication and information-giving skills is evident. The content of training should be aimed at achieving these aspects and empowering patients. Further research is needed to determine the best approaches to achieve these goals.

The purpose of the study is to demonstrate a safe and feasible methodology to evaluate the infection rate in pediatric patients with cancer randomized to the neutropenic diet or the U.S. Food and Drug Administration (FDA)-approved food safety guidelines.

Pediatric patients (aged 1–21 years) undergoing myelosuppressive chemotherapy were randomized to receive a neutropenic diet or a diet based on the FDA food safety guidelines (emphasis on safe handling and cooking). Patients were enrolled during one cycle of chemotherapy.

Primary outcome was febrile neutropenia.  
Secondary outcome was adherence and diet tolerability.

• The sample size was 19.
• The two groups of participants were matched on all variables except history of febrile neutropenia.

Two hospitals in New York

Prospective, randomized, controlled pilot study

• Infection was measured with hospital admission data for febrile neutropenia.  
• Localized infection (along with an ANC less than 500 cells/mm³) also was included.  
• Dietary adherence measured by 24-hour diet recall.
• Student t test measured differences between the groups.

No statistically significant differences in infection was found between the two groups.  
Four patients on each arm developed febrile neutropenia.  
Adherence rate was 94% for neutropenic diet and 100% for FDA-approved food safety guidelines.

• Small sample size.  
• Difficulty adhering to the neutropenic diet was reported.  
• Adherence measured by 24-hour diet recall.

To evaluate changes in cerebral blood associated with a mindfulness-based art therapy program (employing functional magnetic resonance imaging) and correlate such changes to stress and anxiety in women with breast cancer

The Mindfulness-based Art Therapy (MBAT) intervention arm consisted of the basic mindfulness-based stress reduction (MBSR) curriculum paired with expressive art tasks. The design of MBAT was intended to provide opportunities for self-expression, facilitate coping strategies, and improve self-regulation. The MBSR aspect of the MBAT intervention provided standardized tools to help participants observe, assess, and negotiate their objective and subjective experiences of the illness process. A variety of mindfulness meditation techniques were taught during the eight-week program, including body scan, awareness of breathing, awareness of emotions, and mindful yoga, walking, eating, and listening.

• The study reported on 18 female patients with breast cancer.
• Mean patient age was 55 years (range = 45–67).
• Patients received their breast cancer diagnosis between 6 months and three years prior to enrollment and were not in active treatment.

• Urban setting
• Thomas Jefferson University, Philadelphia, PA

• Patients were not receiving active treatment.
• The study has clinical applicability for elder care and palliative care.

A randomized, qualitative study design was used.

Response to the program was evaluated using the Symptom Checklist-90 Revised (SCL-90-R) as a way to rate behavior. The SCL-90-R was obtained pre- and post-MBAT and within one week of the pre- and post-functional MRI scans. The SCL-90-R is a 90-item inventory that assesses nine symptom dimensions and a summary score, the Global Severity Index. Functional MRI scans were also obtained as a way to correlate scores on the SCL-90-R with results of the functional MRI.

Overall, the study showed significant differences in cerebral blood flow in the insula, caudate, and amygdala in patients who underwent an eight-week MBAT program. Given the improvements in anxiety levels (lower scores on the SCL-90-R), these findings suggest that at the level of these brain structures, the MBAT intervention may help to mediate emotional responses in women with breast cancer.

Women who used MBAT techniques had lower scores on the anxiety scale, and also a difference in cerebral blood flow in the insula, caudate, and amygdala regions shown through functional MRI studies. These areas have known correlations with stress and anxiety.

• The study had a small sample, with less than 30 participants.
• The study had risk of bias due to lack of blinding.
• Findings are not generalizable.
• The intervention was expensive, impractical, or required training needs.
• Functional MRI is prohibitively expensive and only available in university settings.

Brief guided imagery or simple meditation techniques could be employed by nurses to relieve patients’ stress and anxiety. Guiding patients toward reading about meditation and guided imagery and encouraging them to try these techniques on their own may also be useful.

To estimate the effectiveness of adjunctive presurgical hypnosis in the control of symptoms after surgery

• Databases searched were MEDLINE and PsycLIT.
• Search keywords were hypnosis or hypnotherapy and surgery or operation.
• Studies were included in the review if they
  • Included administration of hypnosis to at least one group undergoing surgery
  • Included a control or usual-care group
  • Provided statistical data that allowed calculation of effect sizes

Authors did not report

• Total literature evaluated
• Quality rating of studies described or apparently used in the analysis

• Authors analyzed 20 papers.
• The studies the papers described included 1,624 patients. Overall, sample size was 20–339 participants.
• Of the studies analyzed, two studies involved patients with cancer—one involved patients with head and neck cancer and the other involved women undergoing breast biopsy. These two studies involved a total of 52 patients.

Results demonstrated an effect size of D = 1.17 (95% CI 0.41–1.93) in favor of presurgical hypnosis as a means of decreasing pain severity. The effect size regarding impact on pain medication was D = 1.69 (95% CI 0.56–2.82). Results were similar whether hypnosis intervention was provided by tape or by means of a live session. Mean effect size, across several clinical outcome categories in studies involving cancer, was 0.63 in cases of head and neck cancer and 0.9 in cases of excisional breast biopsy.

This analysis demonstrated that adjunctive presurgical hypnosis helped control postoperative pain in the majority of patients undergoing various types of surgery.

• Only two of these studies related to patients with cancer. Both of these studies had small sample sizes.
• The majority of studies did not provide an attentional control condition.
• Authors provided no analysis of heterogeneity among the studies.

Findings suggest a positive effect of presurgical hypnosis, delivered by tape or in a live session, for the management of the postoperative pain of surgical patients. This report and findings are limited by lack of information about how pain was measured, failure to examine heterogeneity in pooled data, and lack of information about the timing of outcome measures. Findings are also limited by the lack of attentional control conditions in the majority of studies and the lack of randomization in more than half the studies. The sample spans about 40 years. This meta-analysis does not provide strong evidence for the use of presurgical hypnosis as a way to decrease the postsurgical pain of patients with cancer.

Both the hypnosis and attention control sessions were standardized and provided for patients individually by clinical psychologists. All four interventionists were PhD-level clinical psychologists trained in the use of hypnosis in medical settings. The hypnosis intervention was provided in a 15-minute session on the morning of surgery one hour before surgery. Sessions included a relaxation-based induction (including imagery for muscle relaxation), suggestions for relaxation and peace, specific symptom-focused suggestions, a deepening procedure, and instructions for how patients could use hypnosis on their own following the intervention session. Patients in the attention control condition spent identical amounts of time with the same interventionists that led the hypnosis intervention. Patients were allowed to direct the flow of the conversation, and therapists provided supportive/empathic comments according to standardized procedures. Patient outcome measures were evaluated before discharge on the same day of surgery. Interventions were based on previously published work.

• The sample included 200 patients with breast cancer (mean age = 48.5 years) scheduled to undergo excisional breast biopsy or lumpectomy. 
• The majority of patients were white (intervention group = 71%, control group = 55%), and about half were married (intervention group = 50%, control group = 45%).
• Patients in the hypnosis group received less intraoperative medications than patients in the control group. 
• Patients were not eligible if they were scheduled for mastectomy or lumpectomy with full axillary dissection or if they had any uncontrolled major comorbid mental or physical illness.

Patients were recruited from two Mount Sinai Medical Center surgical practices.

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial:

1. Hypnosis (n = 105)
2. Attention control (n = 95).

Visual analog scales (VASs)

A MANOVA showed an overall effect of the intervention on the six outcomes (as assessed by VASs), including patient-reported pain intensity, pain unpleasantness, nausea, fatigue, discomfort, and emotional upset (p < 0.0001). One-way ANOVAs of the effects of the intervention on VAS outcomes revealed that each outcome was statistically significantly lower in patients in the intervention group compared to those in the control group. In all cases, mean differences were clinically meaningful.

A cost-effectiveness analysis revealed that the intervention group had reduced costs compared to the patients in the attention control condition. These cost savings were primarily a result of reduced time in surgery in the hypnosis group.

• Patients were not blinded to group assignment because patients in the hypnosis group had to be aware and actively participate in the intervention.
• Formal assessment of the effectiveness of blinding research and clinical staff was not conducted.
• The study did not analyze the long-term effects of the intervention.

To test the effectiveness of a psychological intervention combining cognitive-behavioral therapy (CBT) and hypnosis (CBTH) to treat radiotherapy-related fatigue.

Forty-five patients were randomized to two groups:  CBTH and standard medical care. Weekly and daily fatigue were measured with two covariates:  neuroticism and history of chemotherapy. In the CBTH group, the patients participated in a 15-minute hypnosis session with guided imagery and suggestions for reduced fatigue and a sense of relaxation and energy. Patients were given a CD of the hypnosis intervention to listen to at home. The therapist provided a 30-minute CBT skills session, including how to recognize negative beliefs, consequences of those beliefs, how to change these, and how to practice behavioral strategies and exercise to manage treatment-related fatigue. The therapist reviewed information and progress with each patient twice weekly for a total of 12 sessions in 5- to 15-minute sessions.

• The sample was comprised of 42 patients (100% female). 
• Patients were older than 18 years.
• Mean age was 53.45 years (standard deviation [SD] = 10.43 years) for the CBTH group and 52.78 (SD = 11.65 years) for the control group.
• Patients had breast cancer stage 3 or lower.
• Karnofsky Performance Status (KPS) was 98.75 (SD = 3.19) in the CBTH group and 96.57 (SD = 7.45) in the control group.

• Type1
• Single site
• Urban radiation oncology clinic

The study was a randomized, clinical trial using a repeated measures design.

• Weekly fatigue was measured using the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue Subscale (FS)
• Daily levels of fatigue were measured using a 100-mm visual analog scale (VAS). 
• Possible covariates were neuroticism, measured using the NEO-Five Factor Inventory Neuroticism Subscale (NEO-N) shortened form self-report questionnaire; the second covariate was history of chemotherapy, assessed via medical record review and scored as yes or no.

Among the control group, weekly FSs increased over time at a rate of 1.57 points/week (p < 0.001). Over the course of radiotherapy, individuals in the intervention group had little increase in FS fatigue (0.6 points/week) (p = 0.01).

An intervention combining CBT and hypnosis was effective for controlling fatigue in patients with breast cancer undergoing radiotherapy, independent of neuroticism or past chemotherapy.

• The study had a small sample size, with less than 100 patients.
• The study lacked a sufficient attentional control.

Replication of the intervention effects should be studied in a larger population with appropriate attentional control procedures.

STUDY PURPOSE: To analyze the effects of low-level laser therapy (LLLT) on lymphedema secondary to breast cancer surgery

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 5 
• TOTAL PATIENTS INCLUDED IN REVIEW = 189
• SAMPLE RANGE ACROSS STUDIES: 11–61
• KEY SAMPLE CHARACTERISTICS: All had breast cancer–related lymphedema (BCRL).

PHASE OF CARE: Late effects and survivorship

All studies showed positive results of LLLT compared to control groups, which was most evidenced in studies with longer time frames.

The findings suggest that LLLT may be a treatment option for upper limb lymphedema in women with breast cancer; however, more well designed research is needed.

• Limited number of studies included
• Low sample sizes

More research with larger samples and comparisons to other effective interventions are needed to determine the role of LLLT for lymphedema treatment. LLLT may be a useful adjunct for lymphedema treatment.

To examine infection measures to reduce the transmission of vancomycin-resistant enterococci (VRE).

VRE cultures were obtained from all 259 patients (100%) in 404 admissions to the unit during the use of enhanced infection control strategies and 167 of 184 patients (91%) in 210 admissions to the unit during the use of standard infection control practices.

Enhanced Infection Control

1. Inpatient surveillance: perianal cultures on admission and weekly
2. Hand washing before and after patient contact
3. Contact isolation for VRE-colonized and VRE-infected patients
4. Gown and glove use on entry of rooms of VRE-colonized and ​VRE-infected patients
5. Consultation with infectious disease specialists when infection is first suspected
6. Systematic recommendation by infectious disease specialists to discontinue empirical vancomycin use after 72 hours
7. Systematic recommendation by infectious disease specialists to use oral metronidazole rather than oral vancomycin for Clostridium difficile colitis
8. Spatial separation of patients into three cohorts: VRE-positive, VRE-negative, and VRE-unknown patients
9. Surveillance of perianal cultures taken for inpatients with cancer housed off the oncology unit
10. Gown and glove use on entry of rooms of VRE-unknown patients
11. Assignment of staff cohorts; nurses and nursing assistants assigned to VRE-positive patients or VRE-negative and VRE-unknown patients
12. Patient orientation about VRE with an explanatory brochure
13. Monitoring compliance by observational studies
14. Environmental cultures taken in VRE-positive patient rooms before and after patient discharge and room disinfection

Patients were evaluated during the use of enhanced infection control strategies (n = 259) and standard infection control practices (n = 184).

Eleven-room, 22-bed adult oncology unit in a 650-bed tertiary care hospital

This was a prospective cohort study.

Standard infection control versus enhanced infection control:

• VRE infection rates
• Colonization
• Changes in antimicrobial use.

• VRE colonization was significantly reduced: 8.6 patients per 1,000 days versus 13.2 patients per 1,000 days
• Compliance with enhanced strategies: 91.7% of individuals who entered rooms wore gowns and gloves
• Enhanced infection control strategies: The incidence of VRE bloodstream infections decreased significantly (1.4 patients per 1,000 days versus 3.2 patients per 1,000 days for the standard group).

• No conceptual model was described.
• Single unit where patients were not transferred
• No randomization
• Fifteen infection control measures were implemented simultaneously; therefore, the influence of each intervention is unknown.

To compare the effects of fentanyl and ketamine as premedication before painful procedures in children

Participants scheduled for invasive procedures requiring sedation were randomized to receive either fentanyl or ketamine pre-medication before lumbar puncture for intrathecal chemotherapy or bone marrow biopsy. The treatment was reversed prior to the next procedure each child received. Pain was measured two hours after the procedure when patients fully recovered from sedation, and patients were monitored for 24 hours after the procedure. The average washout period was 5.8 weeks.

• N = 55   
• AGE = 16% were younger than 4, 43.6 % were 4–8 years, and 40% were older than 8
• MALES: 49.1%, FEMALES: 50.9%
• KEY DISEASE CHARACTERISTICS: All had hematologic cancers

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Thailand

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

• Controlled, randomized, crossover trial

• FLACC scale (Faces, Legs, Activity, Cry, Consolability) for those younger than four years
• Wong-Baker FACES pain rating scale for 4–8 year olds
• Visual Analog Scale for Pain (VAS-Pain) for those older than eight years

Pain severity was lower with fentanyl (median 2 versus median 2.44 with ketamine) (p = 0.002). When receiving fentanyl, patients also had less nausea and vomiting post-procedure. Ketamine was associated with side effects of hallucination, nausea, vomiting, and increased salivation. Side effects seen with fentanyl were nausea (9%) and vomiting (3.64%) within 24 hours post-procedure.

Premedication with fentanyl in children prior to invasive procedures was associated with less severe pain and fewer side effects compared to ketamine.

It is unclear if the specific procedures were the same for both study conditions in the crossover. Validity of determination of side effects such as hallucination in the youngest children is questionable—behavioral changes were included in the author's definition of this side effect.

Fentanyl premedication for invasive procedures requiring sedation in children was associated with lower severity of pain after the procedures and fewer side effects compared to ketamine.